(Bizalimogene ralaplasmid + mavilimogene ralaplasmid) is under clinical development by Inovio Pharmaceuticals and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect (Bizalimogene ralaplasmid + mavilimogene ralaplasmid)’s likelihood of approval (LoA) and phase transition for Cervical Intraepithelial Neoplasia (CIN) took place on 25 Jul 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Bizalimogene ralaplasmid + mavilimogene ralaplasmid) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

(Bizalimogene ralaplasmid + mavilimogene ralaplasmid) overview

VGX-3100 (a fixed dose combination of Bizalimogene ralaplasmid (pGX3002) and mavilimogene ralaplasmid (pGX3001)) is under development for the treatment of HPV associated anal dysplasia, cervical intraepithelial neoplasia 2/3 (CIN2/3) and vulvar intraepithelial neoplasia (VIN). VGX-3100 is a therapeutic DNA vaccine candidate administered as intramuscular injection. It targets the E6 and E7 oncogenic proteins of Type 16 and Type 18 HPV. It is based on SynCon DNA plasmid technology, ASPIRE technology and delivered using Cellectra electroporation Delivery System.

Inovio Pharmaceuticals overview

Inovio Pharmaceuticals (Inovio) is a biotechnology company that focuses on developing DNA immunotherapies and vaccines for the treatment and prevention of various cancers and infectious diseases. The company develops products based on its core SynCon DNA plasmid technology and electroporation delivery technology. Its product pipeline includes VGX-3100 for the treatment of cervical HSIL, vulvar HSIL, anal HSIL; INO-5401 for glioblastoma; INO-3107 for recurrent respiratory papillomatosis (RRP); and INO-5151 for prostate cancer. The company is also engaged in development programs in partnership with several companies and government bodies to develop therapeutics for infectious diseases such as HIV, Ebola, Zika virus, Middle East respiratory syndrome (MERS), Lassa fever and COVID-19. Inovio is headquartered in Plymouth Meeting, Pennsylvania, the US.

Quick View (Bizalimogene ralaplasmid + mavilimogene ralaplasmid) LOA Data

Report Segments
  • Innovator
Drug Name
  • (Bizalimogene ralaplasmid + mavilimogene ralaplasmid)
Administration Pathway
  • Intramuscular
Therapeutic Areas
  • Gastrointestinal
  • Oncology
  • Women’s Health
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.